Vioxx On Trial
Key events and litigation involving the safety of Vioxx and other painkillers:
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FDA approves Merck & Co.'s Vioxx, a Cox-2 inhibitor, for treatment of arthritis and acute pain in adults.
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Merck gives FDA results of VIGOR study, which shows Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve. Merck attributes the disparity to naproxen's cardioprotective qualities rather than a defect in Vioxx, but was rebuked by the FDA for making that assertion without scientific proof.
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Merck receives a warning letter from the FDA about the company's post-VIGOR Vioxx promotional campaign "that minimizes the potentially serious cardiovascular findings" and "misrepresents the safety profile of Vioxx."
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FDA changes warning label on Vioxx to reflect VIGOR study results showing increased risk of heart attacks and strokes.
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Carol Ernst sues Merck, alleging Vioxx triggered the May 2001 death of her husband, Robert Ernst, a 59-year-old Wal-Mart produce manager who ran marathons.
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Merck voluntarily withdraws Vioxx from the market after halting a study that it said showed Vioxx could double risk of heart attack or stroke if taken for 18 months or longer. The study had focused on whether Vioxx could prevent reoccurrence of colon polyps, and on cardiovascular effects.
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FDA panel concludes Vioxx and other similar drugs all pose heart risks, but should be available to consumers.
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Texas jury finds Merck liable for the death of Robert Ernst, awarding his widow $253.4 million in damages. That will be reduced to about $26 million under Texas caps on punitive damages; Merck plans to appeal.
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Atlantic County (N.J.) Superior Court jury rules Merck was not responsible for a heart attack suffered by Boise, Idaho, postal worker Federick "Mike" Humeston, who had taken Vioxx for about two months.
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Squeezed by Vioxx lawsuits, tumbling revenues and other troubles, Merck announces it will eliminate 7,000 jobs and five production plants and revamp manufacturing in the first phase of an anticipated global reorganization.
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In the first federal Vioxx case to go to trial, jurors in New Orleans cleared Merck in the death of Richard "Dicky" Irvin, who died after taking Vioxx for about a month. The verdict came on retrial after a federal judge in Houston three months earlier declared a mistrial when a jury failed to reach a verdict in the case.
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A jury in Atlantic City, N.J., split in a two-plaintiff trial, awarding damages to 77-year-old John McDarby, who suffered a heart attack after taking Vioxx, but absolved Merck in the case of 60-year-old Thomas Cona.
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Texas jury finds Merck liable in death of Leonel Garza, a 71-year-old who died after taking Vioxx for less than a month. Garza had suffered from heart disease for 23 years. The jury orders the company to pay $32 million. The case was the sixth of 11,500 lawsuits to reach a verdict. It brings Merck's scorecard in the trials to three wins, three losses.
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The New England Journal of Medicine publishes a correction to the APPROVe Vioxx study indicating the risk of heart problems was elevated soon after people began taking the drug — not only after 18 months of use as Merck still contends.
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A jury in Atlantic City, N.J., rules Merck was not responsible for a heart attack suffered by Elaine Doherty, a 68-year-old diabetic homemaker who had been obese but lost nearly 100 pounds and improved her health years before the heart attack. The case was the seventh of at least 16,000 lawsuits to reach a verdict. It brings Merck's scorecard in the trials to four wins, three losses.
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A state judge in New Jersey overturns Merck's
victory in the Humeston case, saying evidence uncovered since the
November verdict warranted a new trial. She found of particular
note the revelation that Merck left some heart attack data out of its VIGOR report.
A federal jury in New Orleans orders Merck to
pay $51 million to Gerald Barnett, who began taking Vioxx in 2000, had a heart attack Sept. 6, 2002, and continued taking Vioxx until the week before it was withdrawn from the market.
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Federal judge orders a new trial on Barnett's
damages, saying $50 million compensatory is "grossly excessive."
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A federal jury in New Orleans clears Merck in the case of Robert Garry Smith, 56, of Kentucky, who suffered a heart attack in 2003.
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A surge of lawsuits hits courthouses ahead of the second anniversary of Merck withdrawing Vioxx from the market, the deadline for patients in 22 states with a two-year limit on initiating personal injury lawsuits.
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A federal jury in New Orleans clears Merck in the July 2003 heart attack suffered by Charles Laron "Ron" Mason, 64, of Utah.
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A federal judge in New Orleans rules that federal lawsuits over Vioxx cannot be combined into one national class action.
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A federal jury in New Orleans clears Merck in the 2003 heart attack of Anthony Dedrick, 50, of Tennessee.
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Jurors in Birmingham, Ala., clear Merck in the 2001 heart attack suffered by Gary Albright, 57.
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A jury in Atlantic City, N.J., rules against the widow of Brian Hermans, 44, of Wisconsin, but rules Merck violated New Jersey's consumer fraud law, letting the family recoup Vioxx copayments and about $2 million in legal fees.
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In a retrial granted because of new evidence, an Atlantic City jury awards Frederick "Mike" Humeston, 61, of Idaho $47.5 million in damages.
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A jury in Edwardsville, Ill., sides with Merck and rejects claims that Vioxx caused the fatal 2003 heart attack of Patty Schwaller, 52.
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A federal judge dismisses a securities class action lawsuit alleging Merck had defrauded investors by concealing information about Vioxx's safety risks, because the statute of limitations expired.
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FDA rejects Merck's request to market a successor to Vioxx, Arcoxia, two weeks after advisers voted 20-1 against approval.
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New Jersey's Supreme Court rejects a potential class-action lawsuit brought on behalf of health insurance plans seeking to recoup what they paid for Vioxx, setting the stage for individual lawsuits.
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Merck & Co. said it will pay $4.85 billion to end thousands of lawsuits over its painkiller Vioxx in what is believed to be the largest drug settlement ever. The deal becomes binding only if 85 percent of all plaintiffs in about 26,600 lawsuits agree to drop their cases. Merck faced personal injury lawsuits representing 47,000 plaintiffs, and about 265 potential class action cases, filed by people or family members who claimed the drug proved fatal or injured its users.
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Partial payments for people claiming withdrawn painkiller Vioxx caused heart attacks will go out
starting Aug. 28 under the $4.85 billion settlement between
drugmaker Merck & Co. and plaintiffs' lawyers. The payments will amount to about 40 percent of each
plaintiffs' estimated total payout, but it's unclear how many people will be getting checks in the first batch going out.
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Credits:
AP/CBS
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